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The International Legal Regime For Biotechnology Patenting: An Appraisal From The Standpoint of Developing Countries
The International Legal Regime For Biotechnology Patenting: An Appraisal From The Standpoint of Developing Countries
The International Legal Regime For Biotechnology Patenting: An Appraisal From The Standpoint of Developing Countries
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ABSTRACT RESUME
TABLE OF CONTENTS
Introduction 293
Conclusion 324
INTRODUCTION
1. N.D. HAMILTON, "Who owns Dinner : Evolving Legal Rights for Ownership
of Plant Genetic Resources", (1993) 28 Tulsa L. J., pp. 587-657, pp. 689-90, dis-
cussing the benefits of biotechnology.
2. P. BLUNT, "Selective Breeding and the Patenting of Living Organisms",
(1998) 48 Syracuse L. Rev., pp. 1365-1390, pp. 1375-76, discussing the arguments
pro and con the application of genetic-engineering on living organisms.
3. Id., pp. 1375-76, noting that "[t]he risks involved in the development and
the introduction of genetically organisms into the world at large will be balanced
against the expected return on investment [...].
294 Revue générale de droit (2001) 31 R.G.D. 291-326
Seemingly, this is because the issues are raised, for the most
part, in terms which oppose the "haves" and "have-nots", and
the parties ultimately aim either to attain and maintain a
competitive edge on the international market or to meet
development goals. Worth recalling is that one major effect of
IPR is to grant monopoly rights to those who invent new pro-
cesses or products, for a certain period of time before their
inventions are passed on to the public domain. Faced with
this reality, farmers and indigenous communities in devel-
oping countries with huge biological endowments, are
becoming increasingly critical of the patenting of plant vari-
eties and its derivatives. Since biotechnology extends to both
farming and genetic engineering, 4 by promising new eco-
nomic prosperity and industrial uses, it will quite possibly
continue to impact on the political and legal split between
developed nations and developing countries. 5
In this paper we submit that intellectual property law,
as it stands at present with respect to the patenting of biolog-
ical innovations, fails to strike an appropriate balance
between inventors' rights and local communities' rights in
developing countries. This is due to the fact that conflicts still
persist in recent international agreements which have
attempted to address competing interests of the parties
involved. This statement is also based on the assumption that
developing countries are actually willing to exploit their bio-
logical resources; but, they find current international stan-
dards of patentability quite challenging.
Therefore, we start, in Section I, by locating the source of
the current debate in the "customary" link between IPR and
trade, which has been codified in the Agreement on Trade-
Related Aspects of Intellectual Property Rights (TRIPS Agree-
ment). 6 The assessment of the rationale behind this marriage
4. D.S. TlLFORD, "Saving the Blueprints : The International Legal Regime for
Plant Resources", (1998) 30 Case W. Res. J. Int'l L., pp. 373-446, p. 376, arguing that
"[t]oday, biotechnology is helping both farmers and medical researchers sift through
the available genetic options to produce more precisely tailored crops and drugs".
5. Id., p. 397, arguing that the field of biotechnology "promises [...] the battle
over genetic resources".
6. April 15, 1994, [hereinafter TRIPS Agreement], Marrakesh Agreement
Establishing the World Trade Organization, [hereinafter WTO Agreement], Annex IC,
Legal Instruments — Results of The Uruguay Round, vol. 31; 331.L.M. 81 (1994).
BADIMBOLI International Legal Regime for Biotechnology 295
7. March 20, 1883, 21 U.S.T. 1583, 828 U.N.T.S. 305 [hereinafter Paris Con-
vention].
8. December 2, 1961, 33 U.S.T. 2703. This system, which is monitored by the
Union for the Protection of New Varieties of Plants [hereinafter UPOV], has been
amended several times. Recent versions retained for discussion in this paper are
those of 1978 and 1991 [hereinafter UPOV Convention (1978), UPOV Convention
(1991)].
9. June 5, 1992, S. Treaty Doc. N° 103-20 (1993) [hereinafter CBD].
296 Revue générale de droit (2001) 31 R.G.D. 291-326
10. F.M. ABBOT, "Protecting First World Assets in the Third World : Intellec-
tual Property Negotiations in the GATT Multilateral Framework", (1989) 22 Vand.
J. Transnafl L., pp. 689-745, pp. 697-98, arguing that the IPR issue deals with
designing a mechanism to protect intangible wealth transferred from developed
countries to developing countries, therefore, it seems erroneous to base the debate
on the benefits likely to be drawn by developing countries as a consequence of their
cooperation.
11. See generally R.T. RAPP, R.P. ROZEK, "Benefits and Costs of Intellectual
Property Protection in Developing Countries", 24 J. World Trade, pp. 75-102,
pp. 77-81, arguing that the more effectively a country provides patent protection, the
quicker it is likely to achieve economic development (p. 78). To support this assump-
tion, they present an index of patent protection which ranks the level of protection on
a scale of zero to five. Five corresponds to countries that fully comply with minimum
standards proposed in the Guidelines for Standards for the Protection and Enforce-
ment of Patents of the U.S. Chamber of Commerce Intellectual Property Task Force
(p. 79), while zero applies to countries with no patent protection at all. The conclu-
sion, following a "regression analysis" is that Western countries with a strong patent
law experience greater economic development. But see A.S. GUTTERMAN, "The North-
South Debate Regarding the Protection of Intellectual Property Rights", (1993) 28
Wake Forest L. Rev., pp. 89-139, p. 118, n° 207, observing that "the scores were based
solely on the laws as written and did not account for actual enforcement experience".
BADIMBOLI International Legal Regime for Biotechnology 297
cause and effect logic in this issue and even assert that the
international patent system is not fit for developing coun-
tries. 1 2 The outcome of the altercation is that developing
countries adhere to the patent system hoping that it will
arguably prompt investments 13 and transfer of technology;14
but, at the same time, they fear "adverse economic conse-
quences for themselves in general and for research and devel-
opment in agriculture in particular". 15 Their reluctance is
further justified by the fact that patents are overwhelmingly
owned by foreigners and "insignificant number of inventions
[are] induced by [the] patent system" in their countries. 16
The second assumption is that North-based firms experi-
ence financial losses due to inadequate IPR protection in devel-
oping countries. Its justification extends from the fact that
counterfeiting is an unfair trade practice, since it prevents
12. A.S. ODDI, "The International Patent System and Third World Develop-
ment : Myth or Reality?", (1987) 5 Duke L.J., pp. 831-878, p. 842, relying on a critical
study by E. Penrose in 1951, according to which "there is no justification for devel-
oping countries to participate in the international patent system". See also
R.J. GUTOWSKI, "The Marriage of Intellectual Property and International Trade in
the TRIPS Agreement : Strange Bedfellows or a Match Made in Heaven?", (1999) 47
Buff. L. Rev., pp. 713-761, pp. 750-51, arguing that "the evidence of successful indus-
trialization of countries in East Asia, particularly the 'four little dragons' (Taiwan,
Hong Kong, South Korea and Singapore), reveals that the recognition of IPR is not
essential to development, despite the rhetoric of developed nations [...] economic and
political reform rather than legal protection of IP may transform underdeveloped
nations".
13. K.W. McCABE, "The January 1999 Review of Article 27 of the TRIPS
Agreement : Diverging Views of Developed and Developing Countries Toward the
Patentability of Biotechnology", (1998) 6 J. Intell. Prop. L., pp. 41-67, p. 64, arguing
aptly that "[p]atent protection acts as a stimulus for investment, not necessarily
because it offers an expectation of increased profits, but rather because it offers a
mechanism to exclude competitors from copying the subject invention". See also R.J.
GUTOWSKI, loc. cit., note 12, p. 758, pointing to "compelling arguments" for devel-
oping countries to benefit from IPR in the long-run; namely the creation of "incen-
tives for domestic and foreign researchers and entrepreneurs to invest resources in
innovative technologies and solutions to problems indigenous to their countries".
14. A.S. ODDI, loc. cit., note 12, p. 855.
15. M.G. BHAT, "Trade-Related Intellectual Property Rights to Biological
Resources : Socioeconomic Implications for Developing Countries", (1996) 19 Ecolog-
ical Econ., pp. 205-217, p. 205; See also K.W. McCABE, loc. cit., note 13, p. 55 :
"[A]ssuming that the developed countries' arguments are correct and that strength-
ened intellectual property protection will stimulate growth, the developing country
will also spend money to develop its infrastructure in order to support the economic
growth predicted by the developed countries".
16. A.S. ODDI, loc. cit., note 12, p. 855.
298 Revue générale de droit (2001) 31 R.G.D. 291-326
17. K.W. McCABE, loc. cit., note 13, p. 48, arguing that "biological inventions
are particularly susceptible to piracy because, while they typically require substan-
tial expenditures to develop, they are often simple to replicate",
18. D. HARTRIDGE, A. SUBRAMANIAN, "Intellectual Property Rights : The Issues
in GATT", (1989) 22 Vand. J. Transnatï L., pp. 893-910, p. 895 : "The established
industrialized economies are losing comparative advantage in some traditional sec-
tors and are consciously shifting their attention and resources into areas of greater
comparative advantage-activities that are creativity-, research-, and knowledge-
intensive, and therefore intellectual property-intensive".
19. A well-known example is a report produced in 1986 by the United States
International Trade Commission, dealing with "distortions in U.S. worldwide trade
associated with the protection provided by foreign countries to U.S. IPR". This report
estimated that U.S. companies that responded to the questionnaire lost $23.8 billion
in that year. Extrapolating that figure, it was believed that "worldwide losses to
United States industries in 1986 ranged from $43 billion to $61 billion". See F.M.
ABBOT, loc. cit., note 10, p. 700, commenting on U.S. International trade Commis-
sion, Pub. n° 2065, Foreign Protection of Intellectual Property Rights and the Effect
on U.S. Industry and Trade (1988) (Report to United States Trade Representative).
20. V. SHIVA, Biopiracy. The Plunder of Nature and Knowledge, Boston, South
End Press, 1997, p. 11.
21. M.G. BHAT, loc. cit., note 15, p. 208. However, it should be noted that the
Uruguay Round materialized what was difficult to achieve in the Tokyo Round of
Negotiations. The agreement on counterfeiting in that round failed because there
was no "consensus on its incorporation into the final results of the round, since only
the United States and the European Community were prepared to support it at that
time". See D. HARTRIDGE, A. SUBRAMANIAN, loc. cit., note 18, p. 897.
22. R. ACHARYA, "Patenting of Biotechnology : GATT and the Erosion of the
World's Biodiversity", (1991) 25 J. World Trade, pp. 71-87, p. 72, discussing how the
economic crisis of the 1970s led industrialised countries, namely the United States,
to re-examine competition policies.
23. TRIPS Agreement.
BAD EMBOLI International Legal Regime for Biotechnology 299
61. N. ROHT-ARRIAZA, loc. cit., note 41, p. 265; See also GAIA FOUNDATION &
GRAIN, "Ten Reasons Not to Join UPOV. Global Trade and Biodiversity In Conflict",
N° 2 (London/Barcelona, 1998) (visited Dec. 22, 1999) <www.grain.org/publications/
gtbc/issue2.htm>.
62. UPOV Convention (1978), art. 2(1). However, the United States was
excused to apply double protection. It granted breeders' rights under the Plant
Variety Protection Act, 7 U.S.C. §§ 2321-2583 (1970) to "new sexually reproducing
varieties", whereas it granted plant patents for "asexually reproducing plants" under
the 1930 Plant Patent Act, 35 U.S.C. §§ 161-164 (1992); See N.D. HALMILTON,
loc. cit., note 1, p. 595.
63. UPOV Convention (1991), art. 2.
64. As a matter of fact, the European Patent Convention contains a provision
very similar to what is found in the TRIPS Agreement, to be studied below, which
prohibits patents on "plant or animal varieties or essentially biological processes for
the production of plants or animals". This prohibition has been interpreted restric-
tively, as applying only to "varieties per se"; thus, "utility patents can be granted in
cases where claims are not for a variety per se". See N.D. HAMILTON, loc. cit., note 1,
pp. 606-607. For further discussion see infra, note 89 and accompanying text.
65. UPOV Convention (1978), art. 5(3). See also N.D. HAMILTON, id., p. 598,
discussing the scope of these exceptions.
66. N.D. HAMILTON, id., p. 599.
308 Revue générale de droit (2001) 31 R.G.D. 291-326
B. BIOTECHNOLOGY PATENTING IN
THE T R I P S AGREEMENT
72. M , p . 6 1 3 .
73. TRIPS Agreement, art. 33.
74. Id., art. 30, stipulating that the exceptions to exclusive rights will "not
unreasonably conflict with a normal exploitation of the patent and [will] not unrea-
sonably prejudice the legitimate interests of the patent owner, taking account of the
legitimate interests of third parties".
75. CM. CORREA, "Patent Rights", in CM. CORREA, A.A. YUSUF (eds.), Intellec-
tual Property And International Trade : The Trips Agreement, London/Boston,
Kluwer International, 1998, pp. 189-221, p. 208.
76. TRIPS Agreement, art. 31. The general rule is that compulsory licencing
applies only where the attempt to obtain authorization from the right holder on rea-
sonable commercial terms and conditions proves unsuccessful; unless the demand
concerns national emergency or similar circumstances, in which case the right
holder has to be notified and remunerated, taking into account the economic value of
the authorization. Besides, any decision relating to the authorization can be subject
to a judicial or independent review. See also K.W. MCCABE, loc. cit., note 13, p. 61,
noting the extent of severe restrictions to compulsory licencing; CM. CORREA, id.,
p. 210, pointing out that the flexibility as to the grounds for granting compulsory
licences is subject to the conditions specified by the TRIPS Agreement. M. HALE-
WOOD, "Regulating Patent Holders : Local Working Requirements and Compulsory
Licenses at International Law", (1997) 35 Osgoode Hall L. J., pp. 243-287, p. 263,
noting that compulsory licensing provisions "are definitely more restrictive than was
previously allowed for [...]."
310 Revue générale de droit (2001) 31 R.G.D. 291-326
87. CM. CORREA, loc. cit., note 75, pp. 194-195, and by the same author, "The
GATT Agreement on Trade-related Aspects of Intellectual Property Rights : New
Standards for Patent Protection", (1994) 16 Eur. Intell. Prop. Rev., pp. 327-335,
p. 328 [hereinafter, CM. CORREA, "New Standards"].
88. Convention on the Grant of European Patents, Oct. 5,1973,1065 U.N.T.S.
199 [hereinafter, The European Patent Convention].
89. CM. CORREA, loc. cit., note 75, p. 195.
90. The analogy underlying this reasoning seems to be based on the similarity
between article 27.3 of the TRIPS Agreement and article 53(b) of the European
Patent Convention which reads as follows : "European patents shall not be granted
[...] [for] plant or animal varieties or essentially biological processes for the produc-
tion of plants or animals; this provision does not apply to microbiological processes
or the products thereof\ For further discussion of the application of the "human
intervention" standard by the European Patent Office, see W. MOSER, "Exceptions to
Patentability Under Article 53(b) EPC", (1997) 28 Int'l Rev. Ind. Prop. & Copy. L.,
pp. 845-850, pp. 846-849; H.C THOMSEN, "The Exceptions to Patentability Under
Article 53(b) EPC and Corresponding Laws of the EPC Contracting States", (1997)
28 Int'l Rev. Ind. Prop. & Copy. L., pp. 850-857, pp. 852-855.
91. TRIPS Agreement, art. 27.3(b).
BADIMBOLI International Legal Regime for Biotechnology 313
92. CM. CORREA, "New Standards", loc. cit., note 87, pp. 328-329.
93. R.L. GÂNA, loc. cit., note 31, p. 749.
94. M. BLAKENEY, loc. cit., note 47, p. 299, referring to the practice of ethno-
botanists and ethnopharmacologists. See also R. WEISSMAN, loc. cit., note 32, p. 1090,
noting that "corporate botanists and anthropologists rely on third world farmers and
herbalists, especially from indigenous communities that make their home in or live
off of the rain forests, to direct them to plants that they use in local medicines".
95. M. BLAKENEY id., p. 299, arguing that publication "may have the effect of
destroying the novelty of therapeutic claims". See also R.L. GANA, loc. cit., note 31,
pp. 749-750 : "Developed countries are likely to treat such traditional medicines or
cultural knowledge as a product of nature or decide they do not satisfy novelty
requirements".
96. R.L. GANA, id., p. 750, arguing that it is possible for a pharmaceutical com-
pany to "take the raw formula or components of a native medicine and work on it
until it satisfies the patentability requirements". See also R. WEISMAN, loc. cit.,
note 32, p. 1090, asserting that "the pharmaceutical companies are able to synthe-
size chemical substances with mild alterations and patent them".
314 Revue générale de droit (2001) 31 R.G.D. 291-326
99. A thorny question concerns the retroactivity of the CBD with respect to
germplasm collected from developing countries prior to its entry into force, and held
by International Agricultural Research Centres (IARCs). The text does not shed
light on the ownership of seed banks, but rather gives rise to controversies. For a
discussion, see G.B. FRISVOLD, P.T. CONDON, loc. cit., note 26, p. 558; see also
N.D. HAMILTON, loc. cit., note 1, pp. 630-631.
100. CBD, art. 15.1.
101. Id., art. 15.7.
102. i d , art. 15.4.
103. Id., art. 16.2.
104. Id., art. 16.3.
105. C.R. MCMANIS, "The Interface Between International Intellectual Prop-
erty and Environmental Protection: Biodiversity and Biotechnology", (1998) 76
Wash. U.L.Q., pp. 255-279, p. 262, discussing the Unites States's position with
respect to the CBD.
316 Revue générale de droit (2001) 31 R.G.D. 291-326
106. Id., p. 256, p. 262, quoting the United Nations Convention on Biological
Diversity, in 3 U.S. Dep't St. Dispatch 423 (1992).
107. D.G. SCALISE, D. NUGENT, loc. cit., note 52, p. 112, discussing the text of
Message from the President of the United States Transmitting the Convention on
Biological Diversity, with Annexes, Done at Rio de Jan[ei]ro June 5,1992, and signed
by The United States in New York, June 4, 1993, S. Treaty Doc. 20, 103d Cong.,
1 s t Sess. (1993).
108. D.G. SCALISE, D. NUGENT, id., p. 111. But see C.R. MCMANIS, loc. cit.,
note 104, p. 263, challenging the attitude of "reading demons" into the text of article
16 : "[A]ny country that interprets Article 16 as requiring involuntary transfer of
technology must be prepared for the counter-argument that the similar language in
Article 15 requires involuntary transfer of genetic resources, a result no source
country would happily accept", and the same author, quoting D. DUMANOSKI, "U.S. is
Isolated in Opposing Biodiversity Treaty", Boston Globe, June 6,1992, p. 4, quoted in
R.L. MARGULIES, "Protecting Biodiversity : Recognizing International Intellectual
Property Rights in Plant Genetic Resources", (1993) 14 Mich. J. Int'l L., p. 322,
p. 337. See also K. BOSSELMANN, loc. cit., note 26, p. 139, describing article 16 as "the
mirror opposite of Article 15 in that it attempts to define access to technology for
LDCs [less developed countries] in the same way as Article 15 attempts to define
access to genetic resources for DCs [developed countries]". In light of this ambiguity,
it can rightly be argued that the rights provided for in the CBD in favor of developing
countries, are difficult to enforce.
109. CBD, art. 7(j).
110. See supra, text accompanying note 43.
B A D EMBOLI International Legal Regime for Biotechnology 317
115. K.W. McCABE, id., p. 58, discussing the UPOV Convention as a model sui
generis legal regime. See also M. CORREA, "New Standards", note 87, p. 329 arguing
that "[t]he reference to a sui generis regime naturally suggests the breeders's rights
regime, as developed within UPOV [...]". Adding, nevertheless, that "the possibility
is open to combine the patent system with the breeders's rights regime".
116. To give two examples cited by Gaia Foundation & Grain, strawberry
plants from Argentina were barred access to Europe by a US breeder "because they
would compete with plants produced in Europe under the U.S. licence". As concerns
anti-competitive practices, "sugar cane breeders in Latin Americ[al protect their
varieties in neighbouring countries to prevent their exploitation there, and thereby
protect their own exports", GAIA FOUNDATION & GRAIN, loc. cit., note 61, Part. 4.1.
BADIMBOLI International Legal Regime for Biotechnology 319
122. One example is that some years back, Equador and Brazil tried, in vain,
to prevent the exportation of Chinchona (from which quinine is derived) and rubber.
See N.D. HAMILTON, loc. cit., note 1, p. 627, quoting H. HOBHOUSE, Seeds of Change :
Five Plants Transformed Mankind, (1985) and A. SMITH, Explorers of the Amazon,
(1990), pp. 251-284 [complete reference omitted in the citation].
123. Infra, notes 128-130 and accompanying text.
124. CBD, art. 7(j).
125. GAIA FOUNDATION & GRAIN, "TRIPS versus CBD. Conflicts Between the
WTO Regime of Intellectual Property Rights and Sustainable Biodiversity Manage-
ment", Global Trade and Biodiversity in Conflict, N° 1, (1998), (visited Dec. 22,1999)
<http://www.grain.org/publications/gtbc/issuel.htm>.
126. V. TEJERA, "Tripping Over Property Rights : Is it Possible to Reconcile the
Convention on Biological Diversity with Article 27 of the TRIPS Agreement?*, (1999)
33 New Eng. L. Rev., p. 967, p. 984.
BADIMBOLI International Legal Regime for Biotechnology 321
127. States Party to the International Convention for the Protection of New
Varieties of Plants. Status on June 29, 1999, (visited Dec. 22, 1999) <http://
www.upov.org/eng/ratif/index.htm>.
128. K.S. JAYARAMAN, "India Drafts Law to Protects Bioresources", (1997) 390
Nature, p. 108.
129. V. TEJERA, loc. cit., note 126, p. 981, discussing India's resistence to comply
with the WTO's ruling.
130. GAIA FOUNDATION & GRAIN, "Beyond UPOV. Examples of developing coun-
tries preparing non-UPOV sui generis plant variety protection schemes for compli-
ance with TRIPS", July 1999, (visited Dec. 22, 1999) <http://www.grain.org/
publications/reports/nonupo v. htm>.
131. V. TEJERA, loc. cit., note 126, p. 982.
322 Revue générale de droit (2001) 31 R.G.D. 291-326
CONCLUSION
146. But see M. HALEW00D, loc. cit., note 76, pp. 280-281, stating that if these
agreements deal with the same subject matter, "then, based on the Vienna Conven-
tion, TRIPS would prevail over the CBD, and parties to both agreements would be
obliged to comply with TRIPS where the two agreements applied equally to any
given legal initiative".
BADIMBOLI International Legal Regime for Biotechnology 325
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